1. Ethics Overview Policy & Information Team
Research & Enterprise Services

2. Overview Ethics at Newcastle Ethical review - process and risk
Why are they important?
Your role
Ethical review - process and risk
Funded or unfunded?
Key Risks (People, Animals, other)
What you need to do
Forms and Systems

3. Ethics at Newcastle What is ‘Ethics’ at Newcastle?
Everyday and professional ethics
Ensures activity is as beneficial as possible for all involved
Why is it important?
Maximise the benefit and minimise any harm caused by the University’s activities
Who does ethics apply to?
Everybody! Staff, Students and others representing us
What projects does it apply to?
research,
teaching & learning
consultancy
other external work
Essentially ethics is a set of moral principals and there is a distinction between everyday and professional ethics.
e.g. everyday – it is wrong to commit murder &
professional - Hippocratic oath, codes of conduct (BMA) and concordat on research integrity
Everyday ethics-Morals
- Norms of behaviour / conduct
- Acceptable and unacceptable behaviours
You have ethical responsibilities to your colleagues, to yourself (wellbeing and safety) as well as to participants
Professional Context
Rules, guidance (codes of good practice) and laws
Professional norms
Personal ethics
Promote the aims of the research
Promote values essential to collaborative work
Accountability to the public
Public support for research
Ensure the potential benefits are worth the risks
Lead to better science through adoption of best practice
Acting unethically can have a detrimental effect on the participants, the researchers and the University.
Knowledge, Avoidance of error, Truth, Trust, Accountability, Respect (KATTAR)
1/3 of Universities income is directly funded by the public (through RCUK), more indirectly
High quality research is value for that investment
Animal testing; worth it for an anti cancer drug but maybe not for a better shampoo (banned in UK)
Raising standards
Funders require that the university ensure the ethics and governance if any work it sponsors. Misconduct a dismissible offence.

4. Ethical Review Processes - Overview

5. Ethical Review Process - Stage 1 - Unfunded
Complete University Ethics Form:
Answering ‘Yes’ to initial question does not necessarily mean full review.
Low Risk - No Further Action required ( notification).
High Risk – Further review by relevant ethics committee ( notification).
All details of submitted form sent to relevant contact

6. Ethical Review Processes - Important
For identified high risk projects.
Funded projects: Full ethical review must be sought at award stage and be in place before any work can begin.
Unfunded projects: Full ethical review must be sought and in place before any work can begin.
Projects to be reviewed by a Faculty Ethics Committee must complete the online form:
Rarely an outright No!
Different committees have different timescales

7. Risk Area 1 – Humans (clinical)
Covers anyone in the care of the NHS or Social Care System.
Patients alive or recently deceased (including those treated under contracts with private sector providers;
Patients Foetal material and in vitro fertilisation involving NHS patients;
The recent dead in NHS premises (i.e. post mortem material);
Access to and/or use of any records relating to past or present NHS patients;
Human subjects including healthy volunteers where the research may harm their physical or mental health.
Research on tissue samples derived from NHS patients or from participants in trials involving the NHS. (The latter is to cover healthy volunteer studies or controls within studies running through the NHS)
High Risk on Ethics form? NHS REC approval

8. Risk Areas 2 – Humans (non-clinical)
Questions:
Will vulnerable groups be involved?
Will gatekeepers be used?
Will misdirection or lack of consent be utilised?
Will sensitive topics (e.g. sexuality/drug use) be studied?
Will drugs or other substances (food) be administered?
Will any invasive or harmful procedures be use?
Will harm (physical or psychological) be experienced?
Will there be significant financial inducement?
High Risk on Ethics form? Faculty Committee Approval

9. Risk Area 3 - Animals
Animals Scientific Procedures Act (ASPA)1986 defines animals as:
live vertebrates (excluding man), including embryos after half way through gestation, and cephalopods.
- Capable of feeling pain and
- Incapable of advocating for their own welfare
University is committed to the 3Rs:
Replacement - avoiding or replacing the use of animals
Reduction - minimise the number of animals used
Refinement - minimise suffering and improve animal welfare

10. Risk Area 3 - Animals Cont’d…
Questions:
Will you experiment on animals?
Will you observe, manipulate or capture animals?
High Risk on ethics form? AWERB

11. Risk Area 4 - Data Questions :
Will you use, create or transfer of sensitive data?
Will you collect sensitive personal data (DPA 1998)?
Will you collect data governed by statute (OSA 1989)?
Will the data relate to Commercial Contract (Licensing)?
Will the data include convention (client confidentiality – non disclosure agreement)?
Will the data be transferred outside EEA?
High Risk on ethics form? Faculty Research Committee.

12. Risk Area 5 - Environment
Questions:
Will the research damage the environment?
Will emissions be above the permissible UK levels?
Will damage be caused by sampling or fieldwork?
Will there be a detrimental effect on the landscape (including monuments, artefacts and cultural heritage)?
Will research take place in a area of special scientific interest?
High Risk on ethics form? Faculty Ethics Committee

13. Risk Area 6 - International
Questions:
Will research take place outside the European Economic Area (EU + Norway, Iceland and Liechtenstein)?
Issues:
Some funders (ESRC) consider this research increases risk
Research carried out in Singapore and Malaysia can be classed as local for the purposes of Ethics.
High Risk on Ethics form? Faculty Ethics Committee
ESRC requirement “not intrinsically more risky” but more risk to researcher. Few interesting cases where UK norms clash with local custom / standards.

14. Other Risk Considerations
Researcher Safety
Involves going into dangerous / unstable situations
Involves the handling or manipulation of dangerous substances
Involves work outside of a researchers core competence area
Research funder
Research aims are at odds with the University's ethos
Conflicts of Interest
Funding, existing relationships

15. Risks and Review Committees - update
Ethics Submitted
Risk Areas
Outcome %
NHS, Health & Social Care – high risk flags
Full ethical review to be submitted through NHS (NHS REC) approval route 2
Humans in a non clinical setting, data, environment, international – high risk flags
Full ethical review to be submitted to Faculty ethics committed 17
Animals – high risk flags
Full ethical review to be submitted to Animal Welfare Ethical Review Board (AWERB) 3
No high risk flags
No further ethical review needed 76
Already obtained

16. Ethics Overview
Break Questions so far?

17. Full Ethical Review (NHS REC)
Submission of application through HRA Portal (IRAS)
All documents must be uploaded along with all relevant authorisations e.g. sponsor, Chief Investigator
Once application complete, telephone central booking service ( ) to book review.
Offered first available slot and average review period is 30 days (maximum 60 days).
If the application receives a review by a full committee you should attend in person.
Link to HRA Application Process Flowchart

18. Full Ethical Review (AWERB)
Complete all sections of the University Ethics Form.
Provide key documents e.g. permissions.
AWERB serves all faculties and meets monthly.
Reviewed by whole committee signed off by Chair.
Applicants will generally receive a decision and / or recommendations within two weeks of the meeting.

19. Full Ethical Review (Faculty)
Complete all sections of the University Ethics Form
Provide key documents e.g. consent forms
Each faculty has it’s own committee
All committees meet virtually
Reviewed by one/two members and signed off by Chair
Applicants will generally receive a decision and/or recommendations within 20 working days

20. Summary
Consider any potential ethical issues in your project before you start work.
Know what’s expected: from the University, from your profession, from your funder and legally.
Know who’s responsible within the project teams / and across them in the case of collaborative projects.
Get ethical approval in place before you begin.
Review: Projects change and so can ethical issues.

21. Resources
Ethics Toolkit: Sections on; working with participants (consent, confidentiality and culpability), animals, example consent forms, risk and safety, data, funders etc.
MyProjects Proposals – Funded Projects
Lime Survey - All Projects
Training and Support Internal: Is provided on request, either to groups or Requested through URO / Faculty. External: AREC, Clinical Research Networks (Trust Staff) etc.

22. Contacts
Faculty Ethics Committees - FMS: Kimberley - SAgE: Rachel - HASS: Lorna Taylor AWERB: Paul Dearden NHS (at NUTH): Central:

23. Questions ?